Conducting Human Subjects Research in Michigan: Selected State Laws That IRBs Should Know April 2016 Maya R. Kobersy Associate General Counsel University of Michigan

Topics Charitable Gaming Laws Child Protection Law Data Security Breach Reporting FOIA/CRIIA 3

Charitable Gaming Laws: Bingo Act Permits nonprofits to raise money for lawful purposes through bingo games, raffles, and other charitable games awarding prizes Defines “prize” as anything of value (monetary or non- monetary) given for attending or winning a game Defines (in guide) raffle as charging people or requiring them to provide something of value to participate in drawing for a prize Distinguishes between small and large raffles Small: Total value of all prizes for all drawings ≤ $500 per day Large: Total value of all prizes for all drawings > $500 per day 4

Charitable Gaming Laws: Bingo Act Generally requires license for each raffle Application must be submitted by nonprofit’s highest ranking officer Fee depends on nature of game involved and number of drawings BUT creates exception for certain small raffles Total value of prizes ≤ $100 No presale of tickets Single gathering 5

Charitable Gaming Laws: Penal Code Defines game promotion Game of chance For a prize With no consideration Requires descriptions of the following: Area/number of outlets in which will be conducted Accurate prize description Minimum number/value of cash prizes Minimum number of each type of other prizes 6

Scenario #1 IRB at non-profit institution reviews research application that states that PI hopes to encourage participation by offering chance to win 1 of 5 iPads to all who complete survey Any issues with scenario? If so, any ways to fix? 7

Scenario #2 IRB at for-profit institution reviews research application that states that PI hopes to encourage participation by offering chance to win 1 of 3 $25 prizes. Any issues with scenario? If so, any ways to fix? 8

Child Protection Law Defines child as person under 18 Defines child abuse and child neglect as harm/threatened harm to child’s health/welfare If child neglect: By parent/guardian By any other person responsible for child’s health/welfare If child abuse: By any of the above By teacher By member of clergy 9

Child Protection Law Mandates reports by individuals in specified professions – examples include: Teachers Social workers Health care professionals Counselors Encourages reports by all others 10

Scenario #3 PI, a social worker, is conducting a study that asks subjects about physical and emotional abuse (whether inflicted or suffered). Is PI a mandatory reporter? If so, what are implications, if any, for informed consent process? PI interviews 19-year-old subject who discloses having been physically abused two years prior by teacher, who has since retired. Does PI have obligation to report? What if teacher were still teaching? 11

Scenario #4 Same study topic as before, but PI is simply a university professor. Consent form advises subjects that “The study team will keep responses confidential unless required to disclose by law.” Subject discloses that he beat his child at least three times in the past year. Must PI report? Can she? 12

Data Security Breach Reporting Applies to persons and agencies (which include state institutions of higher education) Defines “personal information” and “personal identifying information” Defines “security breach” 13

Data Security Breach Reporting Requires notification to state residents of security breaches if either: Unencrypted/unredacted personal information accessed/acquired by unauthorized person Encrypted personal information accessed/acquired by person with unauthorized access to encryption key Waives notification requirement if breach has not/unlikely to cause substantial loss/injury to, or identity theft re:, state resident 14

FOIA/CRIIA FOIA generally requires public institutions to disclose records, upon request FOIA exempts from disclosure (among other things): Information whose disclosure would constitute clearly unwarranted invasion of privacy Records protected by FERPA (mandatory exemption) 15

FOIA/CRIIA CRIIA adds other FOIA exemptions for public higher education institutions First, CRIIA exempts certain information provided by external sources Must be used only for research purposes Must have been designated as “confidential” by time provided Must be covered by written confidentiality agreement Must keep general description of covered information, source, etc. centrally at higher education institution Cannot be otherwise publicly available Cannot have been submitted as condition of receiving government contract or benefit 16

FOIA/CRIIA Second, CRIIA exempts from disclosure certain other information created by employee or contractor for research or education activities IP, until reasonable opportunity to publish in timely manner in forum intended to convey information to academic community Original works of authorship, until reasonable opportunity to secure copyright registration (cannot exceed 12 months) 17

Questions? 18